Clinical Validation of Self-Pacing Algorithms on Step Length Symmetry in Hemiplegic Populations

The goal of this clinical trial is to evaluate the efficacy of self-pacing algorithms in promoting step-length equalization in people with weakness on one side of the body. The main question it aims to answer is:

• How does walking on a treadmill that uses self-pacing algorithms to adjust speed affect stride length in comparison to walking on a treadmill without self-pacing capability? Researchers will compare study participants to themselves when walking on a self-pacing treadmill compared to walking on a fixed-pacing treadmill to see if a difference exists in the equalization of left- and right-sided stride length.

Participants will walk for two minutes at a self-selected pace to warm up and establish a baseline walking speed. They will then walk for 1 - 3 minutes either on a self-pacing treadmill or a fixed-pacing treadmill. A 3-minute seated rest break will follow. Then participants will walk for another 1 - 3 minutes using the treadmill not used in the first walking trial.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Walking on self-pacing treadmill; Behavioral: Walking on fixed-pacing treadmill

Detailed Description

The chosen treadmill has self-pacing algorithms installed that adjust speed as a person walks. This allows a person to increase or decrease speed as desired throughout a walking session. Researchers have not yet determined the effect of using a self-pacing treadmill on left-right gait equalization among people with acquired hemiparesis secondary to stroke or traumatic brain injury. The researchers will compare measurement data captured by the system software when participants walk on the treadmill with the self-pacing feature turned on versus off. Each walking trial will last 1 - 3 minutes and will occur in a random order during a single research session. The randomization is to ensure that fatigue is not a factor when interpreting results.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68104
      • Quality Living, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current client of Quality Living, Inc., in Omaha, NE
• 19 to 75 years of age
• Speak and understand English
• Can ambulate overground for at least 10 minutes with or without use of aids
• Medically cleared for treadmill exercise
• Hemiparesis secondary to stroke or traumatic brain injury

Exclusion Criteria:

• Has not retained power of attorney for healthcare

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-pacing treadmill walking first, then fixed-pacing treadmill walking	Behavioral: Walking on self-pacing treadmill; Contrast with walking on fixed-pacing treadmill.; Behavioral: Walking on fixed-pacing treadmill; Contrast with walking on self-pacing treadmill.
Experimental: Fixed-pacing treadmill walking first, then self-pacing treadmill walking	Behavioral: Walking on self-pacing treadmill; Contrast with walking on fixed-pacing treadmill.; Behavioral: Walking on fixed-pacing treadmill; Contrast with walking on self-pacing treadmill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking	Non-hemiparetic side step length minus hemiparetic side step length when walking on self-pacing versus fixed pacing treadmill.	1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill during a single experimental session.
Difference in step-length on hemiparetic and non-hemiparetic sides	Length of forward movement of each foot during each walking step as measured in centimeters.	1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill.

Collaborators and Investigators

• Sponsor: Quality Living, Inc.
• Investigators: Study Director: Karen Hux, Ph.D., Quality Living, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 5, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 11, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: gait; hemiparesis; walking; physical therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Injuries, Traumatic; Stroke; Paresis
• Other Study ID Numbers: Impower Tread Mill Validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available in deidentified form from the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No